MAIN PURPOSE OF THE ROLE:
Working under direct supervision, performs a wide range of material transfer and detailed clerical duties related to the receiving, storing, issuing, tracking, disposition, and crediting of returned explanted devices.
Receives returned devices, verifies them against documentation according to established procedures, and stores or forwards such returned goods to the proper location according to identifying factors.
Research internal systems for proper disposition and crediting of returned goods.
Work is closely and continually reviewed to ensure that work assignments are done accurately and completely.
Performs routine assignments using detailed written specified/standardized procedures and specific verbal instructions.
Problems involve recurring, routine situations; usually refer more complex problems to the immediate supervisor or more senior level personnel from within the assigned department.
MAIN RESPONSIBILITIES:
Unpacks returned goods and matches the paperwork to the returned product, following safe biohazard handling procedures when opening explanted devices.
Creates the Return Material Record (RMR), using the Returned Materials Database (RMD), and assigns appropriate codes while indicating Reasons for Return (RFR) and other information necessary to complete entry.
Documents the routing of the device based on the condition of the unit as described in the established working instructions.
Prepares applicable travelers for units that require reprocessing and indicates locations for disposition (e.g., Sunnyvale, etc.).
Modifies or creates the Patient Tracking/Medical Procedure record for implants and/or explants not previously recorded, a necessary.
Creates the Device Master Record for devices not previously entered into the tracking system as required.
Prints and distributes the Returned Material report to the departments indicated in the working instructions.
Retains the original returned material report to forward to the reliability laboratory.
Investigates and troubleshoots problem records, utilizing knowledge of the Patient & Device Tracking database.
Assists in the preparation of reports.
Directs outside inquiries regarding returned devices and correspondence from the field to the appropriate staff.
Prepares field-returned product with all associated paperwork for shipment.
Investigates, locates, and obtains any missing device history for the Device Records Department, as necessary.
Coordinates with Product Reporting and Patient & Device Tracking to resolve any documentation or records with conflicting information.
Notifies supervisor of the need to replenish supplies/materials and of any difficulties that cannot be readily corrected.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),
Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
QUALIFICATIONS:
Education-
High School Diploma / GED
Experience/Background-
Minimum 3 years of progressively more responsible work experience in a related office, clerical, warehouse, and data entry experience as well as experience handling bio-hazardous materials.
Must be able to rotate through all jobs performed in the assigned work group as needed.
The demonstrated ability to understand and comply with applicable FDA, GMP, ISO procedures, and Company operating procedures, processes, policies, and rules is essential.
Basic computer skills, including typing skills, as well as a working familiarity with word processing software and applications.
Must be willing to handle biohazardous materials while wearing protective gear.
A demonstrated working knowledge of and experience with an Enterprise Resource Planning (ERP) system is preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes, and meets deadlines in a timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to maintain regular and predictable attendance.
Occasional or regularly scheduled overtime is a requirement of this position.
The base pay for this position is
$18.70 – $37.40/hourIn specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf